FDA releases its GRAS plan

 

CHICAGO, August 10, 2026 —The U.S. Food and Drug Administration (FDA) on Monday announced its long-awaited proposed rule to modernize oversight of ingredients determined to be Generally Recognized as Safe (GRAS). This represents one of the most significant proposed changes to food ingredient regulation in decades and fulfills a key priority of the Administration's Make America Healthy Again (MAHA) agenda.

What the Proposal Would Do

If finalized, the proposed rule would:

• Require manufacturers to notify FDA whenever they conclude that a substance added to human or animal food is Generally Recognized as Safe (GRAS), replacing the current voluntary notification program.
• Increase transparency by expanding FDA's public inventory of GRAS notifications.
• Provide FDA with greater visibility into substances entering the food supply and strengthen its ability to conduct post-market oversight.
• Establish a streamlined, time-limited submission pathway for substances currently marketed under industry self-GRAS conclusions, allowing FDA to obtain information on existing uses while minimizing unnecessary regulatory burden.
• Preserve the statutory GRAS pathway. Legally, FDA is not eliminating the GRAS exemption - it is proposing to eliminate the ability to rely on an independent GRAS conclusion without notifying FDA. The statutory GRAS pathway remains intact; the notification requirement would become mandatory.

Why This Is Significant
Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to independently conclude that certain food ingredients are generally recognized as safe under their intended conditions of use. Although FDA has operated a voluntary GRAS notification program since 1997 (and finalized it in 2016), companies have not been required to notify the agency when making these determinations.
This proposal would fundamentally change that framework by making GRAS notifications mandatory, increasing public transparency and providing FDA with greater oversight of ingredients entering the food supply.

Current Status
Although FDA and the U.S. Department of Health and Human Services (HHS) announced the proposal today and it is available through the Federal Register's public inspection process, the official Notice of Proposed Rulemaking (NPRM) has not yet been formally published in the Federal Register. Once published, the NPRM will initiate the formal rulemaking process and open the public comment period, during which stakeholders will have an opportunity to submit feedback.
Companies relying on self-GRAS conclusions or planning to introduce new ingredients should begin evaluating how these proposed requirements could affect their regulatory strategy, timelines and documentation.

Next Steps
In this week’s food policy newsletter, I will provide analysis of the published GRAS proposed rule along with an overview of today’s HHS Food Policy Celebration. As part of this celebration, ultra-processed foods (UPF) was discussed, however the white paper on defining UPF will not be released today. “The UPF definition continues to go through an interagency review process and more information on that will be made public in a future time,” Acting FDA Commissioner Kyle Diamantas said. The FDA is celebrating both announcements as major wins for the Administration.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” Diamantas said in a statement. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply. By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research. Together, these reforms represent a significant step toward a more transparent and modern food safety system.”